Senior Manager, Regulatory CMC @ (December 2004 - May 2008)
Scientist @ (June 2001 - December 2004)
Sr. Research Scientist, Analytical Development @ Solvay Pharmaceuticals (January 1999 - January 2001)
Monica E. Education
University of Florida
Doctor of Philosophy - PhD (Analytical Chemistry)
Florida Atlantic University
B.S. (Chemistry)
University of Florida
Ph.D. (Analytical Chemistry)
Monica E. Skills
21 CFR Part 11
Analytical Chemistry
Biotechnology
CAPA
CMC
Change Control
Cleaning Validation
Dissolution
Drug Development
FDA
GLP
GMP
GxP
HPLC
IND
LIMS
Pharmaceutical Industry
Quality Assurance
Regulatory Affairs
Regulatory Submissions
SOP
Technology Transfer
V&V
Validation
Monica E. Summary
Monica E., based in Florida, United States, is currently a Vice President Regulatory Affairs at SSI Strategy. Monica E. brings experience from previous roles at The University of Georgia - International Biomedical Regulatory Sciences Progra, NDA Group - an SSI Strategy Company and Noven Pharmaceuticals. Monica E. holds a Doctor of Philosophy - PhD in Analytical Chemistry @ University of Florida. With a robust skill set that includes 21 CFR Part 11, Analytical Chemistry, Biotechnology, CAPA, CMC and more. Monica E. has 1 emails and 3 mobile phone numbers on RocketReach.
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